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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K200527
Device Name pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur
Applicant
Pjur Group Luxembourg S.A.
87 Esplanade De La Moselle
Wasserbillig,  LU L-6637
Applicant Contact Andrea Giebel
Correspondent
Candace F. Cederman
722 Arjean Dr.
Wilmington,  NC  28411
Correspondent Contact Candace Cederman
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/02/2020
Decision Date 02/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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